U.S. patent number 6,645,219 [Application Number 09/948,064] was granted by the patent office on 2003-11-11 for rotatable penetration depth adjusting arrangement.
This patent grant is currently assigned to Amira Medical. Invention is credited to Steven N. Roe.
United States Patent |
6,645,219 |
Roe |
November 11, 2003 |
Rotatable penetration depth adjusting arrangement
Abstract
An arrangement of interfitting components for adjusting the
penetration depth of a lancet and for stimulating an area
surrounding an incision formed by penetration of a surface of the
skin by the lancet, thereby facilitating the extraction of a sample
of bodily fluid with a minimally invasive incision, the arrangement
includes: a bottom end adapted to be applied to the surface of the
skin, and a top end opposite the bottom end; a longitudinally
moveable lancing member having a sharp end; a stop member setting a
longitudinal travel distance of the lancing member; a bottom
surface adapted to be applied to the surface of the skin, and an
opening in the bottom surface through which the lancing member
projects; a penetration depth defined by the distance between the
end of the lancing device and the bottom surface; an adjusting
mechanism for changing the penetration depth; and a stimulation
mechanism for stimulating the area surrounding the incision and
facilitating the extraction of the sample of bodily fluid.
Inventors: |
Roe; Steven N. (San Mateo,
CA) |
Assignee: |
Amira Medical (Indianapolis,
IN)
|
Family
ID: |
25487203 |
Appl.
No.: |
09/948,064 |
Filed: |
September 7, 2001 |
Current U.S.
Class: |
606/182;
606/172 |
Current CPC
Class: |
A61B
5/150022 (20130101); A61B 5/150068 (20130101); A61B
5/15019 (20130101); A61B 5/150259 (20130101); A61B
5/150412 (20130101); A61B 5/150824 (20130101); A61B
5/15194 (20130101) |
Current International
Class: |
A61B
5/15 (20060101); A61B 017/32 () |
Field of
Search: |
;606/172,182,183,181 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Milano; Michael J.
Assistant Examiner: Pantuck; Bradford C
Attorney, Agent or Firm: Woodard, Emhardt, Moriarty, McNett
& Henry LLP
Claims
We claim:
1. An adjustable arrangement, comprising: a carrier; a guide tube,
the guide tube receiving the carrier in a longitudinally slidable
manner, the guide tube comprises a stop member limiting
longitudinal movement of the carrier; an inner ring, the inner ring
adjustably attached to the guide tube, the inner ring comprising a
bottom surface adapted to contact a surface of the skin and to
depress a ring of body tissue; an outer ring, the outer ring
receiving the inner ring in a longitudinally slidable and
relatively nonrotatable manner; a retainer ring, the retainer ring
receiving the guide tube in a longitudinally fixed and relatively
nonrotatable manner, the retainer ring receiving the outer ring in
a longitudinally slidable and relatively rotatable manner; and
wherein the guide tube further comprises a top end comprising a
retaining section; a plurality of guide slots extending
longitudinally from the top end, each guide slot comprising a stop
surface; a body section; and connecting section comprising an
internally threaded bore.
2. The arrangement of claim 1, wherein the bottom surface of the
inner ring is beveled at an angle of 10 to 65.degree..
3. The arrangement of claim 1, further comprising a lancet received
within the carrier.
4. The arrangement of claim 1, wherein the carrier further
comprises a top end having one or more projections, an elongate
body section, and a bottom section having a central opening.
5. An adjustable arrangement, comprising: a carrier; a guide tube,
the guide tube receiving the carrier in a longitudinally slidable
manner, the guide tube comprises a stop member limiting
longitudinal movement of the carrier; an inner ring, the inner ring
adjustably attached to the guide tube, the inner ring comprising a
bottom surface adapted to contact a surface of the skin and to
depress a ring of body tissue; an outer ring, the outer ring
receiving the inner ring in a longitudinally slidable and
relatively nonrotatable manner; a retainer ring, the retainer ring
receiving the guide tube in a longitudinally fixed and relatively
nonrotatable manner, the retainer ring receiving the outer ring in
a longitudinally slidable and relatively rotatable manner; and
wherein the inner ring further comprises an opening disposed in the
bottom end; a retaining flange forming a longitudinal stop with
respect to the outer ring, and one or more antirotation
projections; a plurality of internal longitudinally extending
ridges receiving the carrier therein; and a connecting section
comprising external threads constructed to mate with the internal
threads of the guide tube.
6. The arrangement of claim 5, wherein the outer ring further
comprises a bottom surface adapted to contact a surface of the
skin; one or more longitudinally extending grooves terminating in a
stop shoulder receiving the one or more antirotation projections of
the inner ring; first and second stop surfaces limiting rotational
movement of the outer ring with respect to the retainer ring; and a
transition surface between the stop surfaces for limiting the
longitudinal movement of the outer ring within the retainer
ring.
7. The arrangement of claim 6, wherein the outer ring further
comprises a bottom flange having alternating projections and
grooves.
8. The arrangement of claim 6, wherein the outer ring further
comprises a body section provided with indicia.
9. The arrangement of claim 6, wherein the transition surface
comprises a plurality of steps.
10. The arrangement of claim 6, wherein the outer ring further
comprises a body section and one or more flexible fingers extending
from a top portion of the body section.
11. The arrangement of claim 6, wherein: the outer ring includes
indicia; and the retainer ring further comprises a bottom flange
comprising a pointer for cooperation with the indicia of the outer
ring.
12. An adjustable arrangement, comprising: a carrier; a guide tube,
the guide tube receiving the carrier in a longitudinally slidable
manner, the guide tube comprises a stop member limiting
longitudinal movement of the carrier; an inner ring, the inner ring
adjustably attached to the guide tube, the inner ring comprising a
bottom surface adapted to contact a surface of the skin and to
depress a ring of body tissue; an outer ring, the outer ring
receiving the inner ring in a longitudinally slidable and
relatively nonrotatable manner; a retainer ring, the retainer ring
receiving the guide tube in a longitudinally fixed and relatively
nonrotatable manner, the retainer ring receiving the outer ring in
a longitudinally slidable and relatively rotatable manner; and
wherein retainer ring further comprises an inner bore comprising a
land having first and second stop surfaces; an elongate body
section; a plurality of retainer projections extending from a top
end of the inner bore receiving a portion of the guide tube; one or
more retention tabs disposed at the top end of the retainer ring
overlying at least a portion of the carrier; and an attachment
formation.
13. An adjustable arrangement comprising: a carrier; a guide tube,
the guide tube receiving the carrier in a longitudinally slidable
manner, the guide tube comprises a stop member limiting
longitudinal movement of the carrier; an inner ring, the inner ring
adjustably attached to the guide tube, the inner ring comprising a
bottom surface adapted to contact a surface of the skin and to
depress a ring of body tissue; an outer ring, the outer ring
receiving the inner ring in a longitudinally slidable and
relatively nonrotatable manner; a retainer ring, the retainer ring
receiving the guide tube in a longitudinally fixed and relatively
nonrotatable manner, the retainer ring receiving the outer ring in
a longitudinally slidable and relatively rotatable manner; and a
first biasing element disposed over the carrier, the first biasing
element retained between projections disposed on a top end of the
carrier and a top surface of the inner ring; and second biasing
element, the second biasing element being retained between a top
surface of the body section of the outer ring and retaining
projections disposed on the retainer ring.
14. The arrangement of claim 13, wherein the first and second
biasing elements comprise coil springs.
15. An arrangement of interfitting components for adjusting the
penetration depth of a lancet and for stimulating an area
surrounding an incision formed by penetration of a surface of the
skin by the lancet, thereby facilitating the extraction of a sample
of bodily fluid with a minimally invasive incision, the arrangement
comprising; a bottom end adapted to be applied to the surface of
the skin, and a top end opposite the bottom end; a longitudinally
moveable lancing member having a sharp end; a stop member setting a
longitudinal travel distance of the lancing member; a bottom
surface adapted to be applied to the surface of the skin, and an
opening in the bottom surface through which the lancing member
projects; a penetration depth defined by the distance between the
end of the lancing device and the bottom surface; adjusting means
for changing the penetration depth; stimulation means for
stimulating the area surrounding the incision and facilitating the
extraction of the sample of bodily fluid; wherein the stimulation
means comprises one or more stimulating members constructed to
depress a ring of body tissue in a manner which at least partially
surrounds the incision; and wherein the components of the
arrangement comprise an outermost ring member concentrically
surrounding the other components, and at least one of the
stimulating members is longitudinally moveable with respect to the
outermost ring member.
16. The arrangement of claim 15, wherein the stimulation means
comprises a beveled surface.
17. The arrangement of claim 15, wherein the adjusting means
comprises means for changing a separation distance defined between
the stop member and the bottom surface in response to relative
rotation between two or more components of the arrangement.
18. An apparatus, comprising: a retainer; a guide coupled to the
retainer in a non-rotatable manner to minimize relative rotation
between the retainer and the guide, the guide having a stop member;
a carrier slidably received in the guide tube, the retainer being
configured to carry a lancet for lancing skin, the carrier having a
portion configured to contact the stop member of the guide to limit
penetration depth of the lancet into the skin; an inner member
defining an opening through which the lancet extends to lance the
skin, the inner member having a skin-contacting surface surrounding
the opening that is adapted to contact the skin, the inner member
being threadedly engaged with the guide for adjusting a distance
between the stop member and the skin-contacting surface in order to
adjust the penetration depth of the lancet; and an outer member
slidably received around the inner member, the outer member having
a skin-engaging surface adapted to engage the skin for expressing
fluid from an incision formed by the lancet.
19. The apparatus of claim 15, wherein: the inner member has an
antirotation tab; and the outer member defines a longitudinal
groove in which the tab is slidably received to minimize relative
rotation between the inner member and the outer member while
permitting relative longitudinal movement between the inner member
and the outer member.
20. The apparatus of claim 19, further comprising a biasing element
positioned between the retainer and the outer member to bias the
outer member against the skin.
21. The apparatus of claim 18, further comprising a biasing element
positioned between the retainer and the outer member to bias the
outer member against the skin.
22. The apparatus of claim 21, further comprising a second biasing
element positioned between the carrier and the inner member to
retract the lancet after lancing the skin.
23. The apparatus of claim 21, wherein the biasing element includes
a coil spring.
24. The apparatus of claim 18, further comprising the lancet.
25. The apparatus of claim 18, wherein the inner member and the
outer member are ring-shaped.
26. The apparatus of claim 25, wherein the retainer and the outer
member each have staircase-shaped surfaces to limit longitudinal
movement of the outer member.
Description
FIELD OF THE INVENTION
The present invention relates to an adjustable assembly. More
particularly, the present invention relates to an adjustable
assembly especially suited for use in a body fluid sampling
device.
BACKGROUND OF THE INVENTION
In the description of the background of the present invention that
follows reference is made to certain structures and methods,
however, such references should not be construed as an admission
that these structures and methods qualify as prior art under the
applicable statutory provisions. Applicants reserve the right to
demonstrate that any of the referenced subject matter does not
constitute prior art with regard to the present invention.
Many medical procedures in use today require a relatively small
sample of bodily fluid. The term bodily fluid is intended primarily
to encompass blood, interstitial fluid, or a mixture of the two,
however, the term could also include urine, saliva, etc. Such
samples are often obtained by lancing or piercing the skin at a
selected location, such as the finger, to enable the collection of
1 or 2 drops of blood.
With the advent of home use tests such as self monitoring of blood
glucose, there is a requirement for a simple, reliable procedure
which can be performed in any setting by a person needing to test,
and which minimizes discomfort to the person being sampled and
tested.
Lancets in conventional use generally have a rigid body and a
sterile needle which protrudes from one end. The lancet may be used
to pierce the skin, thereby enabling the collection of a sample
from the opening created. Blood is commonly taken from the
fingertips, where the supply is generally excellent. The nerve
density in this region causes significant pain in many patients.
Repeated lancing of the fingertips results in callous formation.
This leads to increased difficulty in drawing blood and increased
pain.
Sampling of alternate site, such as earlobes and limbs, is
sometimes practiced to access sites which are less sensitive.
However, obtaining an adequate sample, and transferring the sample
to a test strip or reading device, from such non-fingertip
locations often proves to be difficult.
To reduce the anxiety of piercing the skin and the associated pain,
many spring loaded devices have been developed. U.S. Pat. No.
4,503,856 to Cornell et al. and U.S. Pat. No. 4,517,978 to Levin et
al. are representative of the devices which were developed in the
1980's for use with home diagnostic test products, the disclosures
of which are incorporated herein by reference in their entirety.
Even with the large amount of activity and development in this
area, many conventional devices have undesirable aspects.
U.S. Pat. Nos. 5,879,311; 5,857,983; 6,048,352; 5,951,492;
5,951,493; 5,964,718; and 6,086,545 represent important advance(s)
in this area. The disclosures of these patents are incorporated
herein by reference, in their entirety. Through the constructions
and methods set forth in these patents, adequate samples of bodily
fluid are reliably obtained, even from non-fingertip locations, in
a minimally invasive and substantially pain-free manner.
At least some of the above-mentioned U.S. Patents involve applying
a skin-lancing medium against a skin surface to form an incision
therein, removing the skin-lancing medium from the incision, and
thereafter applying a force to depress the skin in a manner forming
a ring of depressed body tissue in surrounding relationship to the
incision, causing the incision to bulge and the sides of the
incision to open, whereby bodily fluid is forced out through the
opening of the incision. This enables an adequate and adjustable
sample size to be obtained, even from areas of the body in which
the blood supply is less plentiful, with a minimally invasive
lancing procedure.
In this regard, the sampling device can include having a housing
with a lower end. At the lower end of the housing a stimulator
mechanism is provided which is relatively movable with respect to
the housing and which has an end face adapted to engage the skin
surface and bulge open the lanced opening in response to being
pressed one or more times against the skin surface. This
construction facilitates the extraction of the bodily fluid,
thereby enabling an adequate sample to be obtained from a
relatively small lanced incision in the skin surface and reducing
the pain associated with such techniques.
While the above-mentioned construction is clearly advantageous, it
would also be beneficial to provide such a construction and
technique with a simple, user-friendly and reliable way to adjust
the depth of penetration of the lancet into the surface of the
skin.
The are numerous known devices which per se provide an adjustable
depth of penetration of a lancet into the surface of the skin.
U.S. Pat. No. 4,895,147 to Bodicky et al. discloses a lancet
injector which includes an elongate tubular housing, and a
penetration depth selector disposed thereon. The rotatable depth
selector includes a number of variable depth contact edges. These
contact edges present a jagged surface which is exposed on the
outside of the housing. This construction is undesirable, since
such exposed jagged edges could pose a safety concern, and do not
present an aesthetically pleasing form. The aesthetics of such
devices are of particular importance since the users are already
apprehensive due to the traditionally painful nature of the testing
procedure. Thus, a relatively more aesthetically pleasing design
will reduce such apprehension and encourage more frequent use which
is important in situations such as the self-monitoring of blood
glucose content. Moreover, Bodicky et al. does not disclose a
device including a stimulator mechanism which is relatively movable
with respect to the housing. Thus, the device of Bodicky et al. is
not as effective in extracting an adequate sample of bodily fluids,
especially from non-fingertip locations.
U.S. Pat. No. 6,022,366 to Schraga discloses a lancet device
including an adjustable penetration depth mechanism. In one
embodiment, Schraga discloses a device wherein the penetration
depth is adjusted by adjusting the length of the needle holding
member. According to this embodiment, a proximal segment is rotated
relative to a cental segment, thereby increasing or decreasing the
overall length of the needle holding member. During rotation, a
protruding element snaps into and out of grooves provided on the
inner diameter of the proximal segment. However, such a
construction provides for a relatively limited number of
adjustments because only a limited number of grooves can be
disposed upon the inner diameter of the proximal segment, due to
the relatively small size typical in such devices. Moreover, the
device described by Schraga requires that the user remove the cap
member in order to adjust the penetration depth, then the cap
member must be replaced by the user after the adjustment has been
made. This construction is obviously inconvenient to the user, adds
an extra degree of difficulty to the operation of the device, and
could pose a safety hazard due to the potential exposure of the
user to the sharp lancet needle during the adjustment process.
Moreover, the device of Schraga does not include a stimulator
mechanism, or a stimulator mechanism which is relatively movable
with respect to the housing. Thus, the device of Schraga lacks the
desirable degree of effectiveness in extracting an adequate sample
from non-fingertip locations, particularly with a minimally
invasive lancing procedure.
U.S. Pat. No. 5,613,978 to Harding discloses an adjustable tip for
a blood lancet device for causing different depths of skin
puncture. The device of Harding includes an inner sleeve and a
partially enclosed distal end which forms a stop for the shoulder
of the lancet. Rotation of an outer sleeve causes longitudinal
motion between the distal ends of the inner sleeve and outer
sleeve, thereby creating an adjustable double bottom which creates
various puncture depths. However, the device of Harding is for
fingertip sampling. Nowhere does Harding disclose, or even suggest,
that a device having the construction described therein is suitable
for non-fingertip sampling. Moreover, the device of Harding lacks a
stimulator member, much less a stimulator member which is
relatively movable with respect to the housing. Thus, the device of
Harding is not suitable for minimally invasive sampling,
particularly at non-fingertip locations.
U.S. Pat. No. 6,045,567 to Taylor et al. discloses a lancing device
having a spring-loaded lancet holder slidably mounted within a
housing. The device is further provided with a knob on the back of
the device which includes forwardly extending fingers that act to
stop the lancet holder at an adjustable predetermined point after
the device has been fired. Thus, the fingers act to control the
penetration depth of the needle. However, the device of Taylor et
al. is specifically constructed for fingertip sampling. Nowhere
does Taylor et al. mention, or even suggest that the device
constructed as described therein is suitable for non-fingertip
sampling. Moreover, the device of Taylor et al. lacks a stimulator
member, or a stimulator member which is relatively movable with
respect to the housing. Thus, the device of Taylor et al. is not
suitably constructed for non-fingertip minimally invasive
sampling.
U.S. Pat. No. 5,730,753 to Morita describes an assembly which
comprises a cap element for mounting onto an injector. The cap has
a stop which is constructed such that an end of the lancet from
which the lancing member protrudes abuts against the stop during
operation of the device. The device further includes an adjusting
element which engages the cap, as well as a cover element between
these elements. The distance between the stop and an opening along
a direction of the lancet movement is changed by rotating the
adjusting element around an axis of rotation of the lancet ejector.
However, the device described by Morita is heavily dependent upon
the elasticity of the material which makes up the various
components. Thus, this construction is more readily prone to
failure, due to failure of the material from which it is
constructed. This is particularly important since it is beneficial
to construct such devices of relatively inexpensive materials in
order to reduce cost to the consumer. The device of Morita is
specifically constructed for application in finger stick devices.
Thus, Morita give no indication that the device described therein
would be suitable for minimally invasive sampling and non-fingertip
locations. Moreover, the device of Morita does not include a
stimulator member, or a stimulator member which is relatively
movable with respect to the housing thereof.
Thus, it would be desirable to provide an improved assembly which
enables the penetration depth of a lancing member to be adjusted in
a simple yet effective and reliable manner, particularly in devices
which are constructed for the sampling of bodily fluids in
non-fingertip locations, with a minimally invasive lancing
procedure.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an adjustable
assembly which overcomes the problems associated with the prior
art.
According to one aspect, the present invention provides an
adjustable arrangement comprising a carrier; a guide tube, the
guide tube receiving the carrier in a longitudinally slidable
manner, the guide tube comprises a stop member limiting
longitudinal movement of the carrier; an inner ring, the inner ring
adjustably attached to the guide tube, the inner ring comprising a
bottom surface adapted to contact a surface of the skin and to
depress a ring of body tissue; an outer ring, the outer ring
receiving the inner ring in a longitudinally slidable and
relatively nonrotatable manner; and a retainer ring, the retainer
ring receiving the guide tube in a longitudinally fixed and
relatively nonrotatable manner, the retainer ring receiving the
outer ring in a longitudinally slidable and relatively rotatable
manner.
According to a further aspect, the present invention provides an
arrangement of interfitting components for adjusting the
penetration depth of a lancet and for stimulating an area
surrounding an incision formed by penetration of a surface of the
skin by the lancet, thereby facilitating the extraction of a sample
of bodily fluid with a minimally invasive incision, the arrangement
comprising a bottom end adapted to be applied to the surface of the
skin, and a top end opposite the bottom end; a longitudinally
moveable lancing member having a sharp end; a stop member setting a
longitudinal travel distance of the lancing member; a bottom
surface adapted to be applied to the surface of the skin, and an
opening in the bottom surface through which the lancing member
projects; a penetration depth defined by the distance between the
end of the lancing device and the bottom surface; adjusting means
for changing the penetration depth; and stimulation means for
stimulating the area surrounding the incision and facilitating the
extraction of the sample of bodily fluid.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
FIG. 1 is a perspective view of an adjustable assembly according to
the principles of the present invention;
FIG. 2 is an exploded view of the adjustable assembly of FIG.
1;
FIG. 3A is a cross-sectional view taken along line 3--3 of FIG. 1
showing the adjustable assembly at a first setting;
FIG. 3B is also a cross-sectional view taken along line 3--3 of
FIG. 1 showing the adjustable assembly at a second setting;
FIG. 4A is a top view of a lancet carrier according to the present
invention;
FIG. 4B is a side view of the lancet carrier of FIG. 4A;
FIG. 4C is a cross-sectional view taken along line 4C--4C of FIG.
4A;
FIG. 5A is a perspective view of a guide tube according to the
present invention;
FIG. 5B is a side view of the guide tube of FIG. 5A;
FIG. 5C is a cross-sectional view taken along line 5C--5C of FIG.
5B;
FIG. 6A is a perspective view of an inner ring according to the
present invention;
FIG. 6B is a top end view of the inner ring of FIG. 6A;
FIG. 6C is a cross-sectional view taken along lines 6C--6C of FIG.
6B;
FIG. 6D is an enlarged view of area 6D as indicated in FIG. 6C;
FIG. 7A is a side view of an outer ring according to the present
invention;
FIG. 7B is also a side view of the outer ring at a different
orientation;
FIG. 7C is also a side view of the outer ring at yet another
orientation;
FIG. 7D is a cross-sectional view taken along line 7C--7C of FIG.
7B;
FIG. 7E is a bottom end view of the outer ring of FIG. 7A;
FIG. 8A is a perspective view of a retainer ring according to the
present invention;
FIG. 8B is a side view of the retainer ring of FIG. 8A;
FIG. 8C is a top end view of the retainer ring of FIG. 8A;
FIG. 8D is a bottom end view of the retainer ring of FIG. 8A;
FIG. 8E is a cross-sectional view taken along line 8E--8E of FIG.
8D; and
FIG. 8F is a cross-sectional view taken along line 8F--8F of FIG.
8D.
DETAILED DESCRIPTION OF THE INVENTION
The concepts of the present invention will now be further explained
by reference to the following specific embodiments.
Before referencing the drawing figures, an overview of the
construction, principles of operation, and method of the present
invention is provided.
An adjustable assembly of the present invention includes a number
of interfitting components. The adjustable assembly of the present
invention is well-suited for adjusting the skin penetration depth
of a lancing member when the assembly is used in conjunction with,
or as a part of, a bodily fluid sampling device. Thus, the assembly
can be formed as either a separate part that is attached or
otherwise associated with a sampling device, or the assembly can be
formed as an integral part of the overall sampling device.
The assembly carries an lancing member, such as a sharp lancet
needle, that is constructed to pierce the skin surface, forming an
incision therein from which a sample of bodily fluid can be
extracted. The amount and makeup of the sample can be varied,
depending upon penetration depth, location of sampling, amount of
stimulation of the incision, etc.
The assembly has an end that is adapted to be applied to the
surface of the skin. In the description that follows, this end will
be referred to as the "bottom" end, and the opposite end will be
referred to as the "top" end. The lancing member is driven or
propelled toward the bottom end of the assembly, and ultimately
into the surface of the skin. The travel distance of the lancing
member within the assembly is preferably determined by a stop on
one or more of the interfitting components.
One of the interfitting components includes a surface at the bottom
end that is applied to the surface of the skin. This surface
includes an opening through which the lancing member projects upon
traveling within the assembly and engaging a stop member. Thus, the
penetration depth is defined as the distance between the end of the
lancing device or lancet and the above-mentioned surface which
engages the skin.
This penetration depth can be altered by changing the separation
distance between the stop member and the bottom surface of the
component which engages the skin. When the separation between the
stop member and the bottom surface is increased, the extent to
which the lancet needle can protrude from the opening in the bottom
surface is decreased (i.e.--decreasing the penetration depth). When
the separation between the stop member and the bottom surface is
decreased, the lancet needle can protrude further from the opening
(i.e.--increasing the penetration depth).
The adjustable assembly further includes a stimulation means for
stimulating the skin in the area surrounding the incision, thereby
facilitating extraction of the sample of bodily fluid from the
incision. Through this stimulation means, the desired sample can be
extracted with a relatively small, and shallow minimally-invasive
incision. The stimulation means can include one or more members
constructed to engage and depress a ring of body tissue or skin in
a manner which at least partially surrounds the incision.
Preferably, at least one or more of the members is relatively
moveable, at least in the longitudinal direction with respect to a
housing of the sampling device.
FIGS. 1-8F illustrate, at least schematically, a preferred
embodiment of an adjustable arrangement 1 of the present
invention.
The adjustable arrangement 1 of the present invention is
well-suited to be utilized in conjunction with a bodily fluid
sampling device (not shown). It is envisioned that the arrangement
of the present invention could be utilized with a number of
different devices. By way of example, the arrangement is suited for
use with samplers such as the ones disclosed in U.S. Pat. Nos.
5,879,311; 5,857,983; 6,048,352; 5,951,492; 5,951,493; 5,964,718,
the disclosures of which are incorporated herein by reference. The
adjustable arrangement can be in the form of a separate part that
is attached to, or otherwise associated with, such a device (as in
the illustrated embodiment). Alternatively, the arrangement could
be formed integrally with the sampler to form a unitary device.
The adjustable arrangement 1 and one or more of its components can
be formed from any suitable material. For example, the material
could comprise a thermoplastic polymer. Moreover, one or more
components of the adjustable assembly can be formed of a
transparent or translucent material thereby enabling the user to
observe the sampling procedure. This allows the user to visually
determine whether a sample of bodily fluid has been extracted from
the incision, without necessitating removal of the assembly from
the surface of the skin to take it out of the line of sight.
An adjustable arrangement 1 according to the present invention
comprises a number of interfitting components, as best illustrated
in FIGS. 1-3B. The arrangement 1 generally includes a carrier 10
which is adapted to carry a lancet needle L or similar device. The
carrier 10 is slidably received within a guide tube 20. An inner
ring 30 is adjustably attached to the guide tube 20. The carrier
10, guide tube 20 and inner ring 30 are all received within an
outer ring 40, which are received within a retainer, such as a
retainer ring 60.
The inner ring 30 and the outer ring 40 cooperate such that there
is no relative rotation between them. Thus by turning or rotating
the outer ring 40 about the longitudinal axis A, the inner ring 30
is also rotated.
The carrier 10, guide tube 20, inner ring 30 and outer ring 40 are
all received within a retainer ring 60. The outer ring 40 is
rotatable within the retainer ring 60. In the illustrated
embodiment, the arrangement 1 is constructed as a separate part for
use in a sampling device (not shown). Thus the retainer ring 60 is
to be affixed to the sampler device.
The top end of the guide tube 20 is mated with the top end of the
retainer ring 60 in a nonrotatable manner such that the guide tube
20 cannot rotate relative to the retainer ring 60.
Thus, when the outer ring 40 is rotated, the inner ring 30 rotates
also. However, the guide tube 20 is prevented from being rotated
via its connection to the retainer tube 60. This causes a relative
rotation between guide tube 20 and the inner ring 30. As best
illustrated in FIGS. 3A and 3B, according to one embodiment this
rotation is used to alter the distance D1 between the stop member S
and the bottom exterior surface 31 of the inner ring 30, thereby
altering the penetration depth PD of the lancet L. Alternatively,
the bottom of the carrier 10 may "bottom out" by coming into
contact with the bottom interior surface 31' of the inner ring 30,
in which case the surface 31' acts as a stop member.
The arrangement further includes means for stimulating the area of
the incision formed in the skin surface by the lancet. Suitable
stimulation means include mechanical, thermal, electromechanical,
ultrasound, etc. Examples of suitable stimulation means can be
found for example, in U.S. Pat. Nos. 5,951,493 and 5,964,718, the
disclosures of which are incorporated herein by reference.
In the illustrated embodiment, at least the inner ring 30 and the
outer ring 40 act as stimulator members. Upon application of the
arrangement 1 to the surface of the skin, bottom surface 41 of the
outer ring 40 first contacts the surface of the skin. As downward
force is applied by the user, outer ring is forced back up into the
retainer tube 60 under tension supplied by a biasing element 90.
Simultaneously, inner ring 30 is advanced toward the skin until
bottom surface 31 contacts the surface of the skin to depress ring
of body tissue which surrounds the incision.
After the lancet has been driven into the surface of the skin,
forming an incision therein, the user then applies a downward force
onto the sampling device which is translated to the top of the
arrangement 1 and directed downward. This force causes a ring of
body tissue to be compressed in surrounding relationship to the
incision, which causes the sides of incision to pull apart, thereby
facilitating the extraction of the desired sample of bodily fluid.
It is within the scope of the present invention that the pressure
be applied once by the user. Alternatively, the user may release
and reapply the pressure a number of times to effect a "pumping" or
"milking" action, as described in detail, for example, in U.S. Pat.
No. 5,951,493.
According to the above-described embodiment, at least one of the
stimulation members is relatively moveable with respect to the
retainer tube. However, it is within the scope of the present
invention to make the stimulation members stationary with respect
to the retainer tube.
While the above-mentioned components have been referred to as rings
or tubes, it should be understood that it is within the scope of
the present invention to provide such components with any suitable
cross sectional shape, such as oval or polygonal. Moreover, the
terms ring and tube are ones of convenience and should not be
construed as limiting the geometry of dimensions of the components
of the present invention.
The particular construction of individual components of the
arrangement 1 will now be further described.
A carrier 10 constructed according to one preferred embodiment of
the present invention is illustrated in FIGS. 4A-4C. However, the
carrier 10 could have any suitable construction, so long as it
performs its intended function. Namely, to securely hold a lancet
L, receive and transmit a driving force from the associated
sampling device, and to slidably travel within the assembly. In the
illustrated embodiment, the carrier 10 includes one or more ears or
projections 11, 12 at its top end. These projections 11, 12 are
constructed to be slidably received by the guide tube 20. As a
downward force is applied to the carrier, as indicated by the
arrows appearing in FIGS. 3A and 3B, the carrier is forced downward
within the guide tube 20 until the projections 11, 12 engage the
stop member S of the guide tube 20, thereby defining a maximum
travel length of the lancet carrier. The carrier 10 further
includes an elongate body section 13, and bottom section 14 having
a central opening 15 through which the lancet L projects (FIGS. 3A
and 3B).
With regard to the lancet element L, a number of different types
and styles of lancet can be utilized with the arrangement of the
present invention. In fact, the lancet L can comprise any type of
device capable of forming the desired incision in the surface of
the skin. By way of example, the lancet L can comprise a metallic
needle held in a molded plastic element. Alternatively, the lancet
L can comprise multiple projections or barbs, and could be formed
entirely of plastic.
A guide tube 20 formed according to one embodiment of the present
invention is illustrated in FIGS. 5A-5C. The guide tube 20 could
have any suitable construction, so long as it performs its
preferred function. Namely, that it be adjustably connectable to
the inner ring 30, and that it be constructed to guide the movement
of the carrier 10. In the illustrated embodiment, guide tube 20
comprises, starting at its top end, a retaining section 21 which is
mated with, and retained by the retainer ring 60. The retaining
section includes ramping surfaces 22 that facilitate insertion into
the retainer ring 60, engagement slots 23 that mate with retaining
projections disposed on the retainer ring 60, and antirotation stop
surfaces 24 that prevent rotation of the guide tube 20 within the
retainer ring 60. Guide slots 25 are provided at the top end of the
guide tube 20 and extend longitudinally therefrom. Guide slots 25
are designed to slidably receive the projections 11, 12 of the
carrier 10.
As previously noted, the arrangement of the present invention
includes a stop member S which can limit the maximum travel length
of the carrier 10 within the arrangement. This stop member could be
constructed in a number of different ways, so long as the
abovementioned function is performed. For example, the stop member
S can comprise a stop surface, an interfitting mechanical
engagement of two parts such as an interfitting projection and
recess, or an wedging arrangement, etc. In the illustrated
embodiment, the stop member S comprises a stop surface or shoulder
26 provided within the guide slots 25 of the guide tube 20. Thus,
as illustrated in FIGS. 3A and 3B, carrier 10 is permitted to
travel within guide slots 25 until projections 11, 12 of the
carrier 10 engage the stop surfaces 26, which prevent further
longitudinal movement of the carrier 10. Alternatively, depending
upon the particular penetration depth setting, the bottom surface
of carrier 10 may come into contact with the interior bottom
surface 31' of the inner ring 30 before the projections 11, 12
engage the stop S of the guide tube 20.
The illustrated guide tube 20 further includes a cylindrical body
section 27, and an adjustable connecting section 28. The connecting
section 28 can have any suitable construction that connects the
guide tube 20 to the inner ring 30, and permits adjustment between
these two components. In the illustrated embodiment, the connecting
section comprises an internally threaded bore 29 that receives an
externally threaded surface of the inner ring 30.
An inner ring 30 formed according to one embodiment of the present
invention is illustrated in FIGS. 6A-6D. The inner ring can assume
different constructions, so long as it performs its preferred
function. Namely, that it be adjustably connectable to the inner
ring 30, that it be constructed to guide the movement of the
carrier 10, and that it is suitably constructed to act as a
stimulator member. In the illustrated embodiment, the inner ring 30
comprises, starting from its bottom end, surface 31 which is
adapted to contact the surface of the skin surrounding the
incision. Preferably, surface 31 is beveled, forming an angle
.beta. of 10-65.degree., preferably 25-65.degree., thereby
enhancing its ability to stimulate the incision. The beveled
surface 31 is provided with an opening 32 through which the lancet
L passes. Inner ring 30 further includes a retaining flange 33
which defines a longitudinal stop within the outer ring 40 when
inserted therein.
The inner ring 30 also is provided with means to prevent relative
rotation between the inner ring 30 and the outer ring 40, such that
rotation of the outer ring 40 also causes rotation of the inner
ring 30. A number of suitable constructions can be provided for
this purpose. In the illustrated embodiment, flange 33 is provided
with one or more antirotation tabs or projections 34, which are
received in corresponding recesses disposed in the outer ring 40.
This construction permits relative longitudinal movement between
the inner ring 30 and the outer ring 40, but prevent relative
rotation. An adjustable connecting section 35 is provided toward
the top end of the inner ring 30. This connection section can have
any suitable construction that permits and adjustable attachment
between the inner ring 30 and the guide tube 20. In the illustrated
embodiment, inner ring 30 is provided with external threads 36 that
are configured to mate with the internal threads 29 of the guide
tube 20. Thus, the top end of the inner ring is threaded into the
bottom end of the guide tube 20.
As best illustrated in FIGS. 6C and 6D, the mating threads are
formed by teeth having contact faces forming and angle .alpha.,
preferably, .alpha. is approximately 60.degree.. The threads have a
pitch 38 of about 0.240 inches. In an alternative embodiment, the
pitch is about 0.300 inches. The threads on the inner ring are left
handed in orientation.
In the illustrated embodiment, inner ring 30 further includes
inwardly projecting longitudinal ridges 37 that perform a number of
functions. For instance, ridges 37 act to add strength and
structural integrity to the inner ring 30, act to guide the
longitudinal movement of the carrier 10 which travels within the
inner ring 30, and provide a platform at their top end upon which
the lancet carrier biasing element 80 rests (FIG. 6B).
Alternatively, the interior of the inner ring 30 can comprise a
single diameter smooth bore.
An outer ring 40 formed according to one embodiment of the present
invention is illustrated in FIGS. 7A-7E. The outer ring can assume
different constructions, so long as it performs its preferred
function. Namely, that it function, or assist in the function of
stimulating the incision, receive the inner ring 30 in a
longitudinally slidable, but nonrotatable manner, and interact with
the retainer ring 60 such that the outer ring 40 is relatively
rotatable and longitudinally moveable with respect to the retainer
ring 60.
In the illustrated embodiment, outer ring 40 includes, starting
from its bottom end, a bottom flange 41 having a bottom surface 42.
Preferably, bottom surface 42 is beveled. The bottom surface 42 may
be beveled at an angle of approximately 10-65.degree., preferably
25-65.degree. so as to facilitate stimulation of the area
surrounding the incision and to facilitate the overall operation of
the device. Alternatively, bottom surface 42 may be provided with a
different construction which achieves the same objective. Examples
of suitable stimulator constructions are referenced above, and
described in greater detail in U.S. Pat. No. 5,951,493.
The bottom flange 41 can be provided with a construction that
facilitates grasping by the user. For instance, bottom flange 41
can be provided with alternating projections and grooves 43.
One or more longitudinally extending grooves 44 are provided, which
extend from the bottom end of the outer ring 40. These grooves 44
receive antirotation projections 34 on the inner ring 30. The
grooves 44 terminate in a stop shoulder 45 disposed inside of the
outer ring 40. The stop shoulder limits the longitudinal movement
of the inner ring 30 in the direction toward the top end of the
outer ring 40, as illustrated, for example, in FIGS. 3A &
3B.
Outer ring 40 further includes an opening and inner bore 46.
An elongate body section 47 extends from the bottom flange 41. Body
section 47 preferably includes indicia I (FIG. 1), disposed in a
visible location which serve as an indication of the particular
depth setting of the arrangement 1 of the overall device.
The outer ring 40 further includes a mechanism for limiting
rotational movement within the retainer ring 60 over a
predetermined range. A number of different constructions are
possible to accomplish this objective. In the illustrated
embodiment, the body section 47 includes a first stop surface 48
and a second stop surface 49. Stop surfaces 48 and 49 act to limit
the rotation of the outer ring 40 within the retainer ring 60 over
a predetermined range. Stop surfaces 48 and 49 a constructed to
cooperate with corresponding stop surfaces on the interior of the
retainer ring 60, thereby limiting rotation of the outer ring in
both the clockwise and counterclockwise directions.
The adjustable arrangement 1 further comprises a mechanism for
altering its longitudinal position relative to the retainer ring 60
in response to relative rotation between these two components. A
number of constructions are possible to accomplish this
function.
According to one embodiment, as illustrated in FIGS. 3A, 3B, 7A, 7B
and 8F, at the top end of the body section 47, one or more flexible
fingers or projections 51 are provided. These fingers 51 are
rotatably and longitudinally slidably received within the retainer
ring 60. The top surfaces 52 of the fingers 51 are constructed for
engagement with a corresponding transition or stepped surface 73
disposed within the retainer ring 60. Thus, as the outer ring 40 is
rotated, the top surfaces 52 of the fingers 51 will sequentially
engage the longitudinally staggered surfaces 73. Fingers 51 can
also be provided with ratcheting nubs 53 disposed on an exterior
surface thereof. These nubs 53 are optionally constructed to be
received within longitudinal grooves disposed in the interior of
the retainer ring 60. As the outer ring 40 is rotated within the
retainer ring 60, these nubs can jump from one longitudinal groove
to an adjacent longitudinal groove upon application of a
predetermined amount of rotational force by the user, thereby
preventing unwanted rotation or an inadvertent change in the
penetration depth setting of the arrangement 1. The abovementioned
jumping of the nubs from groove to groove also provides an
incremental ratcheting action to the rotational movement of the
outer ring 40, which is beneficial to the precise operation of the
device and may be appealing to the user.
The surface 50 is constructed to cooperate with a corresponding
surface 73 on the retainer ring 60. Surface 50 can be formed in the
manner of a staircase having ascending lands or "steps" 50'. As
outer ring 40 is rotated within retainer ring 60, different steps
50' are brought to oppose the corresponding surface(s) 73 of the
retainer ring 60. Thus, when the outer ring 40 is pushed
longitudinally into the retainer ring 60, the steps 50' will
eventually come into engagement with stepped surface 73 thereby
providing a longitudinal stop to the retainer ring 40.
The retainer ring 60 formed according to one embodiment of the
present invention is illustrated in FIGS. 8A-8F. The retainer ring
can assume different constructions, so long as it performs its
preferred function. For instance, that it fix the arrangement 1 to
a sampling device, retain the guide tube 20, and slidably receives
one or more components of the assembly, while permitting relative
rotation.
As previously noted, the arrangement of the present invention can
be formed as a separate part (as illustrated), or could be
integrated into a sampling device. In the case where the
arrangement forms an integral part of the sampling device, retainer
ring 60 can comprise an integrated portion of the sampling device,
instead of the separate ring of the illustrated embodiment. Thus,
in the following description, the features mentioned below could be
provided on a housing or other portion of a sampling device instead
of on a separate ring of the arrangement.
In the illustrated embodiment, retainer ring 60 comprises, starting
at its bottom end, a bottom flange 61. The bottom flange 61
includes a bottom surface 62, and an opening forming an inner bore
63. The bottom flange 61 may be provided with grasping formations,
such as alternating projections and recesses 64.
An indicator or pointer R may be provided on bottom flange 61,
which cooperates with the indicia I on the outer ring 40 to
indicate and identify the particular setting of the adjustable
arrangement 1.
The inner bore 63 includes longitudinally extending grooves 65 that
are constructed to receive the ratcheting nubs 53 of the fingers 51
on the outer ring 40, in the manner previously described.
The inner bore 63 further comprises a land 66 constructed to
cooperate with the outer ring 40 in the following manner. Land 66
comprises first and second stop surfaces 67 and 68 that are
constructed to limiting the amount of relative rotation between the
outer ring 40 and the retainer ring 60 in both the clockwise and
counterclockwise directions. The land 66 further includes surface
69 which can cooperate with the transition surface 50 of the outer
ring 40 to provide a longitudinal stop for the outer ring 40 as
described above.
An elongate body section 70 extends from the bottom flange 61.
A plurality of retainer projections 71 extend from the inner bore
63. These projections are constructed to mate with the engagement
slots 23 provided on the guide tube 20, thereby positively
retaining and longitudinally locking the guide tube 20 within the
retainer ring 60. A pair of adjacent projections 71 receive guide
tube antirotation stop surfaces 24 therebetween. Thus, guide tube
20 is also prevented from relative rotation within retainer ring 60
by projections 71. It should be noted that other retaining
arrangements are contemplated. For instance, instead of projections
71, an annular rib could be provided on the retainer ring 60, with
recess that mate with the guide tube 20.
One or more retention tabs 72 are further provided at the top end
portion of the retainer ring 60. Retention tabs 72 are constructed
to project inwardly by a sufficient amount so as to overlie and
longitudinally retain projections or flanges 11 and 12 of the
carrier 10 underneath them.
An attachment feature may be provided at the outer periphery of the
top end of retainer ring 50 for connecting the arrangement 1 to a
suitable sampling device. According to the illustrated embodiment,
attachment 73 comprises a groove 74 with locking bump 75 for
receiving an mating projection (not shown).
The arrangement of the illustrated embodiment of the present
invention further includes biasing elements 80 and 90. While
biasing elements 80 and 90 are shown as coil springs in the
illustrated embodiment, it should be understood that the biasing
elements 80 and 90 can take other forms such as leaf springs,
stacked Belville washers, and/or an elastomeric element.
Biasing element 80 fits over the carrier 10 and is retained under
projections 11 and 12 of the carrier 10. The opposite end of the
biasing element 80 rests upon the end of the inner ring 30.
According to a preferred embodiment, the inwardly projecting
longitudinal ridges 37 act as a seat for the bottom end of biasing
element 80. Biasing element 80 functions to provide a return force
for the lancet carrier 10 and the lancet needle L disposed therein.
Thus, after the downward force represented by the arrows shown in
FIGS. 3A and 3B has been removed, and after the lancet L has
penetrated the surface of the skin to form an appropriate incision
therein, biasing element 80 provides a return force that drives the
carrier 10 and lancet L back into the arrangement 1 so that the end
of lancet L is no longer exposed.
One end of biasing element 90 rests on the top surface of the body
section 47 of the outer ring 40. The opposite or top end of the
biasing element 90 is retained under retaining projections 71 of
the retainer ring 60. The biasing element 90 provides a reaction
force in response to upward movement of the outer ring 40 indicated
by the arrows appearing in FIGS. 3A and 3B. This construction
facilitates stimulation of the area surrounding the incision
thereby aiding in the extraction of an adequate sample of bodily
fluid.
An arrangement constructed according to the present invention
provides several important advantages. For instance, the
arrangement provides a relatively simple construction which enables
accurate and reliable adjustment of the penetration depth of a
bodily fluid sampling device thereby enhancing the user's ability
to obtain an adequate sample with a minimally invasive incision.
Moreover, operation of the arrangement has a pleasing "feel" and
appearance to the user, thereby reducing the apprehension
associated with the use of such devices. Importantly, the
arrangement further incorporates a stimulation feature which
enables the adjustable arrangement to extract an adequately-sized
sample of bodily fluid from the incision, from a minimally invasive
incision thereby further reducing pain associated with such testing
procedures.
While the present invention has been described by reference to the
above-mentioned embodiments, certain modifications and variations
will be evident to those of ordinary skill in the art. Therefore,
the present invention is to limited only by the scope and spirit of
the appended claims.
* * * * *